MDCG offers clarity on ‘hybrid’ audits under MDR, IVDR

Regulatory NewsRegulatory News | 06 December 2022 |  By 

The European Commission’s Medical Device Coordination Group (MDCG) has adopted a definition for “hybrid audits” that offers notified bodies flexibility in terms of how long an auditor is physically present on the auditee’s premises for audits conducted by notified bodies under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR).
 
MDCG has encouraged notified bodies to conduct hybrid audits to streamline conformity assessments, recognizing the disruption caused by the COVID-19 pandemic. Stakeholders have also voiced concern that there are not enough notified bodies to conduct audits, which could prevent devices from remaining on the European market. (RELATED: MDCG encourages hybrid audits, other actions to improve notified body capacity, Regulatory Focus, 22 August 2022)
 
Under the newly adopted definition, one or more auditors may be present on the premises of a manufacturer, its supplier(s) and/or its subcontractor(s) “with other members of the audit team participating from elsewhere using information and communication technologies (ICT).”
 
The group also notes that under the MDR and IVDR, there are limits to how hybrid audits can be conducted to ensure manufacturers are following quality management system (QMS) requirements.
 
“The assessment procedure must include an audit on the manufacturer’s premises both for the initial assessment and for the periodic surveillance,” MDCG said. “The same requirement applies, as appropriate, for audits to occur on the premises of the manufacturer’s suppliers and/or subcontractors.”
 
“In addition to the terms ‘premises’ or ‘on the premises’, also ‘on-site’ and ‘off-site’ are used in the MDR and the IVDR to describe where conformity assessment activities take place,” the group added.
 
 
According to MDCG, the auditor and other notified body team members may be present on the auditee’s premises for the duration of the audit, “or for a portion of that time.”
 
“A conformity assessment activity included in the audit plan can be carried out either on the auditee’s premises, from elsewhere or simultaneously from the auditee’s premises and elsewhere,” MDCG said. “The auditee should be involved in any case.”
 
Notified bodies should also make sure they plan sufficient time to audit the relevant processes on the auditee’s premises when their inspectors are physically present, according to the group. MDCG adds that when planning for audits, notified bodies should clearly document what parts of the conformity assessment must be done on the premises and what can be done remotely.
 
It has further asked the Notified Bodies Coordination Group (NBCG-Med) to elaborate on operational elements, including identifying aspects of the auditing process that must be done on the auditee’s premises.
 
MDCG says it may review its position on hybrid audits and make modifications to it based on additional experience.

 

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